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Bayer HealthCare CONTOUR NEXT LINK, User Manual

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Bayer HealthCare CONTOUR NEXT LINK User Manual Download Page 2

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®

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www.bayerdiabetes.com/us

 

Need Help? Call toll free: 1.800.348.8100 (available 24 hours a day, 7 days a week)

 

 Read your C

ONTOUR

 N

EXT

 LINK user guide, the 

M

ICROLET

®

2 lancing device insert and all instructional 

materials provided in your meter kit before testing. Please 
follow all instructions for use and care exactly as described to 
help avoid inaccurate results.

 WARNINGS:

•  The meter and lancing device are for single patient use. 

Do not share them with anyone including other family 
members! Do not use on multiple patients!

1,2

•  Used test strips and lancets are possible biohazards and 

must be disposed of as medical waste.

•  All parts of the kit are considered biohazardous and can 

potentially transmit infectious diseases, even after you 
have performed cleaning and disinfection.

•  Always wash your hands well with soap and water before 

and after testing, handling the meter, lancing device or 
test strips.

For complete instructions on cleaning and disinfecting your 
meter and lancing device, please see page 28.

Indications for Use: 
The C

ONTOUR

®

N

EXT

 LINK wireless blood glucose 

monitoring system is an over the counter (OTC) device 
utilized by persons with diabetes in home settings for 
the measurement of glucose in whole blood, and is for 
single-patient use only and should not be shared. The 
C

ONTOUR

®

N

EXT

 LINK wireless blood glucose monitoring 

system is indicated for use with fresh capillary whole 
blood samples drawn from the fingertip and palm only. 
The system consists of a C

ONTOUR

®

N

EXT

 LINK wireless 

blood glucose meter, C

ONTOUR

®

N

EXT

 test strips and 

C

ONTOUR

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N

EXT

 control solutions.

C

ONTOUR

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N

EXT

 test strips are intended for self-testing by 

persons with diabetes for the quantitative measurement of 
glucose in whole blood samples from 20 to 600 mg/dL.
The C

ONTOUR

®

N

EXT

 control solutions are aqueous glucose 

solutions intended for use in self-testing by people with 
diabetes as a quality control check.
The C

ONTOUR

®

N

EXT

 LINK wireless blood glucose 

monitoring system is intended to be used to transmit 
glucose values to Medtronic MiniMed Paradigm

®

 

REAL-Time Insulin Pumps or Guardian

®

 REAL-Time 

Monitor and facilitate transfer of information to Medtronic 
MiniMed CareLink

®

 Therapy Management Software 

through use of radio frequency communication.
The C

ONTOUR

®

N

EXT

 LINK wireless blood glucose monitoring 

system is not intended for the diagnosis of or screening for 
diabetes mellitus and is not intended for use on neonates.

Information for Safety

Important:

 Examine product for missing, damaged, 

or broken parts. If the test strip bottle is open inside a 
new box of strips, do not use those strips. Contact 
Bayer Diabetes Care Customer Service at 1-800-348-8100 
(available 24 hours a day, 7 days a week) for 
replacement parts.

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84359751_CntrNextLINK_UG_EN_FpBp_v4.indd   i-ii

3/29/12   12:19 PM

3/29/12   12:19 PM

Summary of Contents for CONTOUR NEXT LINK

Page 1: ...Before Meal Before Meal 12 24PM l 11 10 12 24PM l 11 10 Reminder Reminder Notes Notes 12 24 PM METER BG Mg dL Wireless Blood Glucose Monitoring System USER GUIDE Uses Bayer s CONTOUR NEXT blood glucose test strips ...

Page 2: ... glucose monitoring system is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only The system consists of a CONTOUR NEXT LINK wireless blood glucose meter CONTOUR NEXT test strips and CONTOUR NEXT control solutions CONTOUR NEXT test strips are intended for self testing by persons with diabetes for the quantitative measurement of glucose in whole blood s...

Page 3: ...ing sections in this user guide Talks to Your Compatible Medtronic MiniMed Device Bayer s CONTOUR NEXT LINK meter can automatically send your blood glucose result directly to your compatible Medtronic MiniMed device This eliminates the need to manually enter your blood glucose result into the insulin pump s Bolus Wizard calculator that calculates and suggests a bolus or correction dose if needed B...

Page 4: ...ferences Warranty 76 Rechargeable Battery Your Bayer s CONTOUR NEXT LINK meter has a permanent rechargeable battery Before you do anything else charge your meter with the wall charger included with your kit You may also charge your meter by plugging the USB connector into a computer Be sure the computer is turned on and not in sleep hibernate or power saving mode Your meter will briefly display Do...

Page 5: ...re End Insert this end into test strip port with gray end face up Sample Tip Blood is drawn in here Bayer s CONTOUR NEXT LINK Blood Glucose Monitoring System Bayer s CONTOUR NEXT LINK blood glucose monitoring system works with Bayer s CONTOUR NEXT test strips USB Connector Meter Front Meter Overview Using the Buttons Bayer s CONTOUR NEXT LINK meter is simple to use Every screen gives you choices T...

Page 6: ...le Medtronic MiniMed device Your compatible Medtronic MiniMed device must be nearby 1 Press and hold the Menu button until the meter turns on After a welcome screen you will see the Select Language screen Using the Menu Button To turn on the meter press and hold the Menu button until the meter turns on The Main Menu has 3 choices Logbook Trends and Setup Select one by pressing the button next to y...

Page 7: ...e the connection process Follow the meter instructions to change the date and time IMPORTANT Refer to the compatible Medtronic MiniMed device user guide for instructions on connecting Bayer s CONTOUR NEXT LINK meter to your compatible Medtronic MiniMed device A screen message will confirm the choice made Ask Me Meter will ask you before sending results Never Meter will never send results If you se...

Page 8: ...mits feature alerts you when you go above or below the settings you choose Alerts appear as large orange numbers see page 34 You can select No Mark if you are testing at times other than before or after a meal Your meter comes with AutoLog turned on We recommend that you keep this feature turned on to get the most benefit from your meter features AutoLog can be turned off in Setup if you choose to...

Page 9: ...single use only Do not use a test strip that appears damaged or has been used Your test strip is designed to easily sip the blood into the sample tip Do not drop blood directly on the flat surface of the test strip Do not press the test strip against your finger when testing This may block the sample tip Let the meter and test strips adjust to the temperature where you are testing Whenever the met...

Page 10: ...terile after use See pages 28 32 for instructions on cleaning and disinfecting your meter and lancing device Do not perform a blood glucose test when the CONTOUR NEXT LINK meter is connected to an external device e g computer Use only approved equipment from the manufacturer or certified body such as UL or TUV Bayer s CONTOUR NEXT LINK meter only works with CONTOUR NEXT test strips and CONTOUR NEX...

Page 11: ...OLET 2 lancing device insert for complete instructions For Alternative Site Testing instructions see page 20 1 To remove the endcap hold the device with your thumb on the grip indent and hold the endcap dial in the other hand Snap the endcap off from top to bottom 5 Replace the gray endcap WARNING Potential Biohazard The MICROLET 2 lancing device is intended for single patient use only The MICROLE...

Page 12: ...ses even after you have performed cleaning and disinfection Always wash your hands well with soap and water before and after testing handling the meter lancing device or test strips For complete instructions on cleaning and disinfecting your meter and lancing device please see page 28 4 Immediately touch the tip of the test strip to the drop of blood The blood is pulled into the test strip through...

Page 13: ...time discard that strip and start over with a new strip Follow the instructions on the meter screen Removing the Used Lancet 1 In one hand hold the lancing device with your thumb on the grip indent with your other hand hold the gray endcap dial as shown and gently snap off the endcap 5 Dispose of the used lancet as medical waste Do not reuse lancets Use a new MICROLET lancet each time you test 2 P...

Page 14: ... driving a car or operating machinery For calibration of CGM System Alternative Site Testing should not be used for Bolus Wizard to calibrate a device or verify a low blood glucose level Consult your health care professional to determine if AST is right for you For Alternative Site Testing on the Palm of the Hand with C ONTOUR N EXT Test Strips 1 Attach the clear AST endcap to the MICROLET 2 lanci...

Page 15: ...strip port to help you test in the dark Insert a test strip and the display screen will appear Once blood is applied to the test strip the light will go off Continue with your test Two quick presses of the Menu button will turn the light off With the meter off give the Menu button two quick presses to turn on the test strip port light Testing with AutoLog On Before your test result is displayed th...

Page 16: ...l be based on those settings Your test result shows as large numbers and then changes to the normal test result screen Testing with AutoLog Off After applying blood to the test strip when AutoLog is turned off your result will appear after the 5 second countdown see page 54 You may now set a Reminder or add a Note Depending on what you have chosen in setup you will have the option to send your tes...

Page 17: ... or not If you have selected Ask Me you can always send or not send to your compatible Medtronic MiniMed device Test Results Expected Values Blood sugar values will vary depending on food intake medication dosages health stress or activity Non diabetic plasma glucose concentrations are normally maintained within a relatively narrow range roughly 70 110 mg dL in the fasting state 3 You should consu...

Page 18: ...isk for Transmitting Bloodborne Pathogens Initial Communication 2010 http www fda gov Medical Devices Safety AlertsandNotices ucm224025 htm CDC Clinical Reminder Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens 2010 http www cdc gov injectionsafety Fingerstick DevicesBGM html Cleaning Your Meter Supplies Needed for Cleaning Clorox Germicidal Wipes...

Page 19: ... Using a new Clorox Germicidal Wipe carefully wipe all outer surfaces of your meter until wet Do not allow cleaning solution to run into the meter through areas such as around the buttons or the meter s test strip or data ports 2 Dry all meter surfaces and test strip port using a clean paper towel if needed Disinfecting Your Lancing Device Supplies Needed for Disinfecting Clorox Germicidal Wipes c...

Page 20: ...uring Range Disinfecting Your Lancing Device For proper disinfection you must keep all lancing device surfaces wet for 60 seconds Signs of Deterioration Your MICROLET 2 lancing device has been tested for 260 cycles of the cleaning and disinfection procedure one cycle per week for 5 years The MICROLET 2 lancing device has been demonstrated to withstand 5 years of cleaning and disinfection without d...

Page 21: ...TOUR NEXT control solutions with Bayer s CONTOUR NEXT LINK blood glucose monitoring system Using any other control solution can cause incorrect results Perform a control test When using your meter for the first time When you open a new bottle or package of test strips If you think your meter may not be working properly If you have repeated unexpected blood sugar results Always use Bayer s control ...

Page 22: ...lood glucose testing until you resolve this issue 3 Prepare to run a control test by inserting a test strip into the meter 4 Gently rock the control bottle before opening to ensure it is mixed well 5 Squeeze a small drop of control solution onto a clean non absorbent surface such as a piece of wax paper Do not apply control solution to your fingertip or to the test strip directly from the bottle 6...

Page 23: ...was set You can change the Reminder Countdown time to the time you wish by pressing the Change button Setting a Reminder A Reminder for your next test can be set after testing or from the Setup menu After Testing 1 Press the Reminder button 1 Press the or button to select the correct hours Press the OK button 2 Press the or button to select the minutes in 15 minute increments Press the OK button A...

Page 24: ...the Countdown is currently on the screen will read Reminder In with the remaining amount of time displayed 2 To stop the Countdown press the Stop button A screen confirms your choice From the Setup Menu 1 Go to the Main Menu Press the Setup button 3 To start the Countdown press the Start button or press the Change button to scroll to a different Countdown time Follow the instructions on the previo...

Page 25: ...sting within 15 minutes of the Reminder neither screen will appear and the Countdown will be stopped Getting a Reminder When the Reminder time is reached 20 beeps will sound The meter will turn on and a Reminder screen will appear You can stop the beeps by pressing the OK button or inserting a test strip From the Setup Menu 1 Press the OK button 2 Press the Stop button The Countdown is now stopped...

Page 26: ... button next to your choice To go back a screen press the Menu button once The Main Menu has 3 choices Logbook Trends and Setup Menu Button To turn on the meter press and hold the Menu button until the meter turns on Menu Button Adding Notes Adding Notes You may add Notes to your test result that may help explain results Your notes will be saved in the Logbook 2 Press the or button to scroll throu...

Page 27: ...to display the 14 Day Before Meal Average This example shows that your Before Meal average is 128 mg dL and 38 test results are included in the Before Meal average with 26 in the target range 8 over your target range and 4 under the target range 3 Press the button to go to the 14 Day After Meal Average The most recent result is shown first and the oldest result last When you reach the oldest entry...

Page 28: ...rs to your compatible Medtronic MiniMed device Setup 6 Choose Connection from the Pump Options menu to connect your CONTOUR NEXT LINK meter to your compatible Medtronic MiniMed device 7 Press OK to continue the connection process Press Go Back if you do not wish to continue the connection Pump Options Go to the Pump Options in the Setup menu if you want to change your original choices 1 Make your ...

Page 29: ...Setting the Time 1 Press the Menu button to go to the Main Menu 2 Press the Setup button 3 Press the or button to select Time Press the OK button 4 To change the date press the Change button 5 Select either the 12 hour clock or 24 hour clock button Setting the Date 1 Press the Menu button to go to the Main Menu 2 Press the Setup button 3 Press the or button to select Date Press the OK button 7 Pre...

Page 30: ...Done button and the Setup menu will appear If you need to make changes press the Change button and repeat the process Turning the Sound On Off Sound is turned ON when you receive your meter It can be turned off using the Setup menu Some error messages and the Reminder bell will override the Sound Off setting One long beep indicates a confirmation Two beeps indicate an error or situation that requi...

Page 31: ...No Mark or if the result is outside the high low limits 1 Press the or button to select AutoLog Press the OK button To keep the AutoLog on press the Accept button Changing the Blood Glucose Target Range Your CONTOUR NEXT LINK meter comes preset with 70 130 mg dL for Before Meal testing and 70 180 mg dL for After Meal testing Ranges can be changed to personal targets decided by you and or your heal...

Page 32: ...cept to use the default settings The default high limit is 250 mg dL and the default low limit is 70 mg dL 2 The next screen will confirm your selection A screen confirms that all target ranges are set If correct press the Done button You will be returned to the Setup menu To make changes press the Change button and repeat the process 1 The default setting for the Trends Range is 14 days To choose...

Page 33: ...dtronic MiniMed device to CareLink Personal Therapy Management Software using your CONTOUR NEXT LINK meter 1 Refer to the CareLink Personal Therapy Management Software user guide for instructions on how to set up CareLink and load the required drivers onto your computer 2 If you are running Bayer s GLUCOFACTS DELUXE diabetes management Software on your computer you must close it 3 Start up CareLin...

Page 34: ...MiniMed device and the device is set to accept meter results Your meter ID must be programmed into the device Refer to the separate Medtronic User Guide Check the device display to see if your meter s glucose result has been received If it has not you can enter the test result manually If you continue to have problems contact Bayer Diabetes Care Customer Service at 1 800 348 8100 available 24 hour...

Page 35: ...ies of low battery alerts will tell you that the battery is low and to charge soon If you do not charge the battery a display will alert you Shutting Down Battery is dead Charge immediately Plug the meter into your wall charger or computer Be sure your computer is turned on and not in sleep hibernate or power save mode Please be aware that USB ports in some computers and self powered USB hubs can ...

Page 36: ...a computer with current anti virus software installed and running Wall Charger For information about your wall charger please refer to the insert contained in your meter kit You can run a blood glucose test as soon as Rapid Charge is complete Rapid Charge If the battery is low when you plug in your meter it will Rapid Charge for about 1 minute End of Meter Life Battery Removal NOTE Carry out this ...

Page 37: ...w blood sugar Hypoglycemia High blood sugar Hyperglycemia Ketones Ketoacidosis shakiness sweating fast heartbeat blurred vision confusion passing out irritability seizure extreme hunger dizziness frequent urination excessive thirst blurred vision increased fatigue hunger shortness of breath nausea or vomiting very dry mouth System Performance Information Capillary samples may be drawn from the fin...

Page 38: ...ately 5 7 per hour Limitations Altitude Up to 20 674 feet 6301 meters does not significantly affect results Lipemic Specimen Cholesterol concentrations 1168 mg dL or triglyceride concentrations 4709 mg dL may produce inaccurate results Peritoneal dialysis solutions Icodextrin does not interfere with CONTOUR NEXT test strips Limitations Limitations Xylose Do not use during or soon after xylose abso...

Page 39: ...ease the separation between the equipment and receiver This portable transmitter with its antenna complies with FCC IC RF exposure limits for general population uncontrolled exposure If you have questions please contact Bayer Diabetes Care Customer Service at 1 800 348 8100 available 24 hours a day 7 days a week Within 5 mg dL Within 10 mg dL Within 15 mg dL Acceptance criteria in ISO 15197 2003 a...

Page 40: ...m and none of the problem solving messages on the meter help call Bayer Diabetes Care Customer Service In the USA call toll free 1 800 348 8100 available 24 hours a day 7 days a week We have trained specialists to help you Important Speak to a Bayer Diabetes Care Customer Service Representative before returning your meter for any reason He she will give you the information needed to handle your pr...

Page 41: ...re emissions from nearby electronic equipment likely to interfere with the CONTOUR NEXT LINK Immunity to electrostatic discharge meets the requirements of IEC 61000 4 2 It is advisable to avoid use of electronic devices in very dry environments especially if synthetic materials are present The CONTOUR NEXT LINK meter has been tested for radio frequency interference at the frequency range and test ...

Page 42: ...est strips to excessive humidity heat cold dust or dirt See page 28 32 for instructions on cleaning and disinfecting your meter The USB cap of your CONTOUR NEXT LINK meter is designed to protect the USB port Should you lose the cap call 1 800 348 8100 available 24 hours a day 7 days a week for a replacement References 1 FDA Public Health Notification Use of Fingerstick Devices on More than One Per...

Page 43: ...nt Manufacturer s Warranty Bayer Diabetes Care war rants to the original purchaser that this instrument will be free from defects in materials and workmanship for 5 years from the date of original purchase except as noted below During the stated 5 year period Bayer Diabetes Care shall at no charge replace a unit found to be defective with an equivalent or current version of the owner s model Limit...

Page 44: ...ons 74 Target Range 55 Transferring Data 59 Index After Meal marker 8 Alerts High and Low Settings 9 Alternative Site Testing AST 20 AutoLog Meal Markers 8 Averages Trends 46 Batteries 62 Charging 64 Low Batteries 62 Replacement 65 Before Meal Marker 8 Blood Sugar Readings 34 Care and Maintenance 75 Cleaning and Disinfection 28 Control Testing 35 Error Detection Displays 61 Lancing 14 84359751_Cnt...

Page 45: ...wners Bayer the Bayer Cross CONTOUR GLUCOFACTS MICROLET and the No Coding logo are registered trademarks and No Coding is a trademark of Bayer Bayer HealthCare LLC Mishawaka IN 46544 USA www bayerdiabetes com us Call Toll Free 1 800 348 8100 available 24 hours a day 7 days a week www bayerdiabetes com us 2012 Bayer All rights reserved 84359751 Rev 04 12 ...

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